12354 Federal Register / Vol. 89, No. 33 / Friday, February 16, 2024 / Notices 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–D–5259 for ‘‘Master Protocols for 

Drug and Biological Product 

Development.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Scott N. Goldie, Center for Drug 

Evaluation and Research, Office of 

Biostatistics, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 21, Rm. 3557, Silver Spring, 

MD 20993–0002, 301–796–2055; or 

James Myers Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 22, 2023, 

FDA published a notice of availability 

for a draft guidance entitled, ‘‘Master 

Protocols for Drug and Biological 

Product Development.’’ This action 

opened a docket with a 60-day comment 

period. The Agency received requests 

for an extension of the comment period 

for the draft guidance. After considering 

the requests, and in light of the fact that 

the original comment period is 

scheduled to close on February 20, 

2024, FDA has decided to extend the 

comment period for 30 days, until 

March 21, 2024. The Agency believes 

that this extension allows adequate time 

for interested persons to submit 

comments to ensure that FDA can 

consider the comments before it begins 

work on the final version of the 

guidance. 

Dated: February 13, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03296 Filed 2–15–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidances; Draft and 

Revised Draft Guidances for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of 

additional draft and revised draft 

product-specific guidances. The 

guidances provide product-specific 

recommendations on, among other 

things, the design of bioequivalence 

(BE) studies to support abbreviated new 

drug applications (ANDAs). In the 

Federal Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website. The guidances 

identified in this notice were developed 

using the process described in that 

guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 16, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 


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Federal Register / Vol. 89, No. 33 / Friday, February 16, 2024 / Notices 12355 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2007–D–0369 for ‘‘Product-Specific 

Guidances; Draft and Revised Draft 

Guidances for Industry.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Christine Le, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4714, Silver Spring, 

MD 20993–0002, 301–796–2398, PSGQuestions@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs. 

As described in that guidance, FDA 

adopted this process as a means to 

develop and disseminate productspecific guidances and provide a 

meaningful opportunity for the public to 

consider and comment on those 

guidances. Under that process, draft 

guidances are posted on FDA’s website 

and announced periodically in the 

Federal Register. The public is 

encouraged to submit comments on 

those recommendations within 60 days 

of their announcement in the Federal 

Register. FDA considers any comments 

received and either publishes final 

guidances or publishes revised draft 

guidances for comment. Guidances were 

last announced in the Federal Register 

on November 17, 2023 (88 FR 80315). 

This notice announces draft productspecific guidances, either new or 

revised, that are posted on FDA’s 

website. 

II. Drug Products for Which New Draft 

Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

new draft product-specific guidances for 

industry for drug products containing 

the following active ingredients: 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS

Active ingredient(s) 

Abacavir sulfate; Dolutegravir sodium; Lamivudine. 

Adagrasib. 

Amoxicillin; Clarithromycin; Vonoprazan fumarate. 

Amoxicillin; Vonoprazan fumarate. 

Baclofen. 

Budesonide; Formoterol fumarate; Glycopyrrolate. 

Caffeine; Ergotamine tartrate. 

Durlobactam sodium; Durlobactam sodium; Sulbactam sodium. 

Elagolix sodium, estradiol, norethindrone acetate; Elagolix sodium. 

Ferric derisomaltose. 

Finasteride; Tadalafil. 

Flotufolastat F–18 gallium. 

Formoterol fumarate; Glycopyrrolate. 

Lenacapavir sodium (multiple reference listed drugs). 

Mannitol (multiple reference listed drugs). 


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12356 Federal Register / Vol. 89, No. 33 / Friday, February 16, 2024 / Notices 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

Active ingredient(s) 

Naloxone hydrochloride. 

Niraparib tosylate. 

Olutasidenib. 

Rivaroxaban. 

Sertraline hydrochloride. 

Sodium phenylbutyrate. 

Sodium phenylbutyrate; Taurursodiol. 

Terlipressin acetate. 

Testosterone undecanoate. 

Xenon Xe-129 hyperpolarized. 

Zanamivir. 

III. Drug Products for Which Revised 

Draft Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

revised draft product-specific guidances 

for industry for drug products 

containing the following active 

ingredients: 

TABLE 2—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS

Active ingredient(s). 

Aclidinium bromide. 

Aclidinium bromide; Formoterol fumarate. 

Albuterol sulfate. 

Aprepitant. 

Betamethasone dipropionate; Clotrimazole (multiple reference listed drugs). 

Budesonide. 

Dapsone (multiple reference listed drugs). 

Dexamethasone; Neomycin sulfate; Polymyxin B sulfate. 

Dexamethasone; Tobramycin (multiple reference listed drugs). 

Diazepam. 

Doxepin hydrochloride. 

Ferric carboxymaltose. 

Fluorometholone. 

Fluticasone furoate; Umeclidinium bromide; Vilanterol trifenatate. 

Fluticasone propionate (multiple reference listed drugs). 

Fluticasone propionate; Salmeterol xinafoate (multiple reference listed drugs). 

Hydrocortisone; Neomycin sulfate; Polymyxin b sulfate. 

Loteprednol etabonate (multiple reference listed drugs). 

Loteprednol etabonate; Tobramycin. 

Mometasone furoate. 

Nilotinib hydrochloride. 

Salmeterol xinafoate. 

Umeclidinium bromide. 

Umeclidinium bromide; Vilanterol trifenatate. 

Vandetanib. 

For a complete history of previously 

published Federal Register notices 

related to product-specific guidances, go 

to https://www.regulations.gov and 

enter Docket No. FDA–2007–D–0369. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidances, when 

finalized, will represent the current 

thinking of FDA on, among other things, 

the product-specific design of BE 

studies to support ANDAs. They do not 

establish any rights for any person and 

are not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

IV. Paperwork Reduction Act of 1995 

FDA tentatively concludes that these 

draft guidances contain no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

V. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, http://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: February 9, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03300 Filed 2–15–24; 8:45 am] 

BILLING CODE 4164–01–P 


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